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KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class II

FDA Device Classification

Classification Details

Product Code
KFM
Device Class
Class II
Regulation Number
870.4360
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251762spectrum medicalQuantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NAugust 4, 2025
K250326spectrum medicalQuantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NJune 24, 2025
K233091quraQuantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)October 26, 2023
K232132cardiacassistLifeSPARC SystemAugust 3, 2023
K220842quraQuantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum PMay 19, 2023
K200091terumo cardiovascular systems corporationCapiox iCP Centrifugal PumpNovember 18, 2021
K201320quraQuantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorNovember 3, 2021
K193663international biophysics corporationFloPump 57mL Centrifugal PumpMarch 10, 2021
K202169quraQuantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal BloodSeptember 2, 2020
K201068medtronicAffinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with BalaMay 21, 2020
K192850quraQuantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal BloodApril 13, 2020
K191077medtronicAffinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with BalaAugust 27, 2019
K190650sorin group italiaRevolution Centrifugal Blood PumpAugust 7, 2019
K183623cardiacassistLifeSPARC Pump, LifeSPARC ControllerJuly 9, 2019
K170029international biophysics corporationFloPump 32mL, Sterile, FloPump 32mL, Non-SterileDecember 15, 2017
K132712medtronicAFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERNovember 19, 2013
K133265maquet cardiopulmonaryQUADROX-IR ADULT AND SMALL ADULTNovember 12, 2013
K112229terumo cardiovascular systemsSARN CENTRIFUGAL PUMPDecember 9, 2011
K110493cardiacassistTANDEMHEART PUMPSeptember 20, 2011
K111972medtronicAFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFJuly 27, 2011